@article{f8e753ce11ed4a72bd17e3656d2c2a0c,
title = "WHO guidance on COVID-19 vaccine trial designs in the context of authorized COVID-19 vaccines and expanding global access: Ethical considerations",
abstract = "While the degree of COVID-19 vaccine accessibility and uptake varies at both national and global levels, increasing vaccination coverage raises questions regarding the standard of prevention that ought to apply to different settings where COVID-19 vaccine trials are hosted. A WHO Expert Group has developed guidance on the ethical implications of conducting placebo-controlled trials in the context of expanding global COVID-19 vaccine coverage. The guidance also considers alternative trial designs to placebo controlled trials in the context of prototype vaccines, modified vaccines, and next generation vaccines.",
keywords = "Placebo-controlled trials, Research ethics, Standard of care, Standard of prevention, Trial designs",
author = "Singh, {Jerome Amir} and Sonali Kochhar and Jonathan Wolff and Caesar Atuire and Anant Bhan and Ezekiel Emanuel and Ruth Faden and Prakash Ghimire and Dirceu Greco and Calvin Ho and Suerie Moon and Ehsan Shamsi-Gooshki and Aissatou Tour{\'e} and Beatriz Thom{\'e} and Smith, {Maxwell J.} and Upshur, {Ross E.G.}",
note = "Funding Information: This work was supported by the United Kingdom Foreign, Commonwealth & Development Office (FCDO) and the Wellcome Trust (Grant 214711/Z/18/Z). JAS receives support from the COVID-19 Africa Rapid Grant Fund (UID 130270), which has been jointly established by the National Research Foundation (NRF) of South Africa, the Canadian International Development Research Centre (IDRC), the Swedish International Development Cooperation Agency (SIDA), the United Kingdom (UK) Department for International Development (DFID), UK Research and Innovation (UKRI) through the Newton Fund, South Africa{\textquoteright}s Department of Science and Innovation (DSI), and Fonds de Recherche du Qu{\'e}bec (FRQ). Funding Information: This policy brief was developed by the World Health Organization Access to COVID-19 Tools Accelerator Ethics and Governance Working Group. The drafting of the document was led by Jerome Amir Singh (Scientific Advisory Group of Emergencies [SAGE], Academy of Science of South Africa; University of KwaZulu-Natal, South Africa and University of Toronto, Canada), with guidance from the Co-Chairs, Sonali Kochhar (University of Washington, Seattle, United States; Global Healthcare Consulting, India) and Jonathan Wolff (University of Oxford, United Kingdom), and input from the members of the Working Group (ordered alphabetically by surname): Caesar Atuire (University of Ghana, Ghana), Anant Bhan (Yenepoya University, India), Ezekiel Emanuel (University of Pennsylvania, USA), Ruth Faden (Johns Hopkins University, USA), Prakash Ghimire (Tribhuvan University, Nepal), Dirceu Greco, (Federal University of Minas Gerais, Brazil), Calvin Ho (University of Hong Kong, China), Suerie Moon (Graduate Institute, Geneva, Switzerland), Ehsan Shamsi (Tehran University of Medical Sciences, Iran), Aissatou Tour? (Institute Pasteur, Senegal, ret.), Beatriz Thom? (University of Sao Paolo, Brazil), Max Smith (Western University, Canada), Ross Upshur (University of Toronto, Canada). Dean Follmann (National Institute of Allergy and Infectious Diseases, USA), Lars Hemkens (University of Basel, Switzerland) and Peter Smith (London School of Hygiene & Tropical Medicine, UK), provided additional input on methodological issues. Katherine Littler and Andreas Reis (WHO Health Ethics & Governance Unit) provided support for the WHO Secretariat. Contributions from Rog?rio Gaspar, Ryoko Miyazaki Krause, Deus Mubangizi, Sergio Andrade Nishioka, David Wood (WHO Regulation and Prequalification Department), as well as Patrik Hummel (WHO Consultant), Owen Schaefer (National University of Singapore), and the WHO Ethics & COVID-19 Working Group are duly acknowledged. Editorial assistance of Deanntha Kanniah (SAGE), is duly acknowledged. This work was supported by the United Kingdom Foreign, Commonwealth & Development Office (FCDO) and the Wellcome Trust (Grant 214711/Z/18/Z). JAS receives support from the COVID-19 Africa Rapid Grant Fund (UID 130270), which has been jointly established by the National Research Foundation (NRF) of South Africa, the Canadian International Development Research Centre (IDRC), the Swedish International Development Cooperation Agency (SIDA), the United Kingdom (UK) Department for International Development (DFID), UK Research and Innovation (UKRI) through the Newton Fund, South Africa's Department of Science and Innovation (DSI), and Fonds de Recherche du Qu?bec (FRQ). Publisher Copyright: {\textcopyright} 2022",
year = "2022",
month = mar,
day = "25",
doi = "10.1016/j.vaccine.2022.02.038",
language = "English (US)",
volume = "40",
pages = "2140--2149",
journal = "Vaccine",
issn = "0264-410X",
publisher = "Elsevier BV",
number = "14",
}